ANDA 084115

UPSHER SMITH LABS

FDA Drug Application

Application #084115

Application Sponsors

ANDA 084115

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

CHLORPROMAZINE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1974-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1982-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1982-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1984-06-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1985-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1985-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1986-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1986-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1986-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1987-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1987-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1987-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1988-04-14
LABELING; Labeling	SUPPL	69	AP	1988-03-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	1988-07-05
LABELING; Labeling	SUPPL	71	AP	1988-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	1989-04-14
LABELING; Labeling	SUPPL	73	AP	1990-11-29
LABELING; Labeling	SUPPL	74	AP	1991-12-31
LABELING; Labeling	SUPPL	75	AP	1992-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	1996-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1999-03-22
LABELING; Labeling	SUPPL	78	AP	1999-03-22
LABELING; Labeling	SUPPL	79	AP	2002-11-25
LABELING; Labeling	SUPPL	94	AP	2008-11-19
LABELING; Labeling	SUPPL	97	AP	2009-08-24
LABELING; Labeling	SUPPL	100	AP	2010-12-03
LABELING; Labeling	SUPPL	103	AP	2011-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	107	AP	2016-08-29	UNKNOWN
LABELING; Labeling	SUPPL	108	AP	2017-02-23	STANDARD
LABELING; Labeling	SUPPL	112	AP	2020-02-05	STANDARD

Submissions Property Types

SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	49	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	70	Null	0
SUPPL	72	Null	0
SUPPL	76	Null	0
SUPPL	77	Null	0
SUPPL	97	Null	7
SUPPL	100	Null	7
SUPPL	103	Null	15
SUPPL	107	Null	15
SUPPL	108	Null	15
SUPPL	112	Null	7

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84115
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPROMAZINE HYDROCHLORIDE","submission":"CHLORPROMAZINE HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)